Although cancer patients with human immunodeficiency virus (HIV) have historically been excluded from cancer clinical trials, researchers are attempting to close — or at least shrink — the treatment gap for these patients.

“It’s important to realize that people with HIV have always been at increased risk for about 8 different types of cancers, including lymphomas, cervical and anal cancer, lung cancer, and head and neck cancer,” said Thomas Uldrick, MD, deputy head of global oncology at Fred Hutchinson Cancer Research Center, Seattle, Washington, during an interview with Cancer Therapy Advisor.

Immunotherapy research that includes HIV patients can answer whether a treatment is safe and effective for patients with HIV and offer meaningful information — information that historically has been absent from research. For example, earlier this year, Dr Uldrick authored a journal article that evaluated pembrolizumab in advanced cancer patients with HIV, concluding that the immune checkpoint inhibitor was safe.1  

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Most recently, separate studies examining the use of adoptive cell therapies in 2 patients answered not only whether chimeric antigen receptor (CAR) T-cell (CAR-T) therapy was safe and effective for HIV patients with refractory high-grade B-cell lymphoma, but also whether it was possible in the first place, given the low CD4 counts patients with HIV often have.2 The clinical trials that evaluated axicabtagene ciloleucel and tisagenlecleucel excluded patients with HIV from enrolling in clinical trials, and as a result, there is a dearth of evidence about the safety and efficacy of these medications in this particular patient population.

“That’s kind of the underlying problem with excluding patients with HIV from clinical trials,” said Dr Uldrick. Furthermore, he said, B-cell lymphoma, for which axicabtagene ciloleucel is indicated, is the second-leading cause of cancer death in people with HIV. “It’s actually an area where one would want to include patients with HIV.”

The study showed that despite low CD4 counts for both patients studied — 52 cells/mm3 for one patient and 127 cells/mm3 for the other — axicabtagene ciloleucel was successfully manufactured and infused in both circumstances.

The diffuse large B-cell lymphoma went into complete remission for both patients:  One patient remained in remission at 1-year follow-up, and the other patient is still being followed. The toxicity seen in the patients resembled what one would expect for a person without HIV: One patient had grade 2 cytokine release syndrome and grade 3 neurotoxicity, while the other had neither cytokine release syndrome nor neurologic toxicity.